Job Description
Job Description
The Extrusion Technician provides technical support to Aptyx's extrusion manufacturing operations within commercial and medical device environments. This role is responsible for setting up, operating, troubleshooting, cleaning, and maintaining extrusion equipment in accordance with established standards and ISO 13485 quality system requirements. The Extrusion Technician ensures product quality, accurate documentation, effective raw material management, and safe operations while serving as a technical mentor to team members.
ESSENTIAL FUNCTIONS
- Set up, operate, monitor, and adjust extrusion manufacturing equipment in accordance with established process parameters and work instructions.
- Troubleshoot equipment and process issues to minimize downtime and maintain product quality.
- Perform in-process quality inspections to ensure product compliance and identify defects.
- Use precision measurement tools including calipers, micrometers, pin gauges, vision systems, and laser micrometers.
- Complete production and quality documentation in compliance with Good Manufacturing Practices (GMP) and ISO 13485 requirements.
- Take appropriate action to ensure quality limits, efficiency targets, and production goals are achieved.
- Monitor raw material usage and accurately track production throughout assigned production lots.
- Perform raw material handling, mixing, and blending per approved formulations and procedures.
- Conduct full machine clean-outs, resets, changeovers, and equipment cleanups as required.
- Maintain an organized, clean, and safe work area in accordance with 5S, safety, and environmental standards.
- Work independently with minimal supervision while maintaining accountability for assigned tasks.
- Adhere to all applicable Aptyx policies, procedures, and regulatory requirements related to health, safety, and environmental compliance.
- Train and mentor extrusion operators and peers as assigned.
- Perform other duties as assigned.
ADDITIONAL RESPONSIBILITIES / TECHNICAL SKILLS
- Perform complex medical extrusion processes, including multi-lumen, multi-layer, and bump tubing.
- Provide effective feedback and support while assisting with task delegation to peers.
- Apply basic mathematical skills including addition, subtraction, multiplication, and division of decimals and fractions.
- Demonstrate understanding of weights, measures, and metric systems.
- Read and interpret precision measuring instruments and technical documentation.
- Apply strong troubleshooting, critical thinking, and problem-solving skills.
- Communicate effectively both verbally and in writing.
- Demonstrate flexibility to support varying manufacturing schedules and production demands.
- Perform all work in compliance with GMP and ISO 13485 requirements.
- Work safely within established safety guidelines and procedures.
REQUIRED QUALIFICATIONS
- High School Diploma or GED required; Technical High School diploma or Associate's degree in a STEM-related field preferred.
- Minimum of two (2) years of experience in a manufacturing environment or demonstrated equivalent technical capability.
- Experience working within a controlled quality system (e.g., ISO 9001 and/or ISO 13485); medical device manufacturing experience preferred.
- Experience with melt extrusion processes required.
- Ability to lift up to 50 lbs occasionally, with frequent lifting of less than 20 lbs.
- Ability to stand for extended periods while monitoring and operating equipment.
PREFERRED QUALIFICATIONS
- Experience in medical tubing or polymer extrusion manufacturing.
- Prior experience supporting regulated medical device production environments.
- Demonstrated mentoring or informal leadership experience.
WORK SCHEDULES
1st Shift
- Monday - Friday: 8:00 AM - 4:30 PM
2nd Shift
- Monday - Friday: 4:00 PM - 12:30 AM
- Shift ends Saturday morning
3rd Shift
- Sunday - Thursday: 12:00 AM - 8:30 AM
- First shift begins Sunday at midnight (Monday morning)
- Final shift ends Friday morning at 8:30 AM
PHYSICAL DEMANDS & WORKING CONDITIONS
- Manufacturing environment with exposure to machinery, noise, and temperature variation.
- Prolonged standing and repetitive motion required.
- Use of Personal Protective Equipment (PPE) is required.
- Working conditions are typical of a regulated manufacturing environment.